Heel Warming Before Capillary Blood Sampling

NCT04995393 | Completed

• 1 other identifier: S-20200082
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

Capillary blood sampling from the heel is often used in the treatment of infants admitted to neonatal intensive care (NICU). In Danish NICUs a heated blanket, a heated gel pad or a disposable glove with warm water are the methods most often used. The purpose of this randomized controlled study is to investigate which of the mentioned heating methods ensures the best quality of the blood sample and provides the most gentle blood sampling for the infant.

Conditions

Blood Specimen Collection

Keywords

Blood Specimen Collection; Phlebotomy; Infant, Newborn; Heating; Heel; Pain

Outcome Measures

Primary Outcomes (2)

• Speed of blood sampling

  µl blood/sec

  10 minutes

• Duration of blood sampling

  Sec

  10 minutes

Secondary Outcomes (4)

• Hemolysis index for potassium of the blood sample

  2 hours

• Degree of squeezing the infants foot during blood sampling

  1 minute

• Number of heel punctures required to obtain the blood sample

  10 minutes

• ComfortNeo score of the infant during the blood sampling

  20 minutes

Study Arms (3)

Glove

ACTIVE COMPARATOR

A heated glove containing water.

Procedure: Heating with a disposable glove containing water

Blanket

ACTIVE COMPARATOR

A heated blanket.

Procedure: Heating with a blanket

Gel pack

ACTIVE COMPARATOR

A heated gel pack.

Procedure: Heating with a gel pack

Interventions

Heating with a disposable glove containing water PROCEDURE

Heating of the infants heel with a glove before blood sampling.

Glove

Heating with a blanket PROCEDURE

Heating of the infants heel with a blanket before blood sampling.

Blanket

Heating with a gel pack PROCEDURE

Heating of the infants heel with a gel pack before blood sampling.

Gel pack

Eligibility Criteria

• Age: 2 Hours - 77 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• PMA (postmenstrual age) ≥ 28+0
• Blood sampling performed by a Biomedical Laboratory Scientist

You may not qualify if:

• GA (gestational age) ≥ 44+0
• Weight \> 6000 g
• Coagulation related disorder
• Severe illness/disorder
• Heel is bruised or swollen
• Parents not understanding written Danish language

Sponsors & Collaborators

• Kolding Sygehus: lead
• Region of Southern Denmark: collaborator
• Development and Innovation Fund at Lillebaelt Hospital: collaborator
• The Research Council for Sygehus Lillebælt: collaborator
• Sygekassernes Helsefond: collaborator
• The Biomedical Laboratory Scientist Education and Research Fund: collaborator

Study Sites (1)

Neonatal intensive care (NICU), Lillebaelt Hospital, University Hospital of Southern Denmark

Kolding, Region Southern Denmark, 6000, Denmark

Location

Related Publications (10)

• Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.

  PMID: 24866853 BACKGROUND

• Anand KJ; International Evidence-Based Group for Neonatal Pain. Consensus statement for the prevention and management of pain in the newborn. Arch Pediatr Adolesc Med. 2001 Feb;155(2):173-80. doi: 10.1001/archpedi.155.2.173.

  PMID: 11177093 BACKGROUND

• Losacco V, Cuttini M, Greisen G, Haumont D, Pallas-Alonso CR, Pierrat V, Warren I, Smit BJ, Westrup B, Sizun J; ESF Network. Heel blood sampling in European neonatal intensive care units: compliance with pain management guidelines. Arch Dis Child Fetal Neonatal Ed. 2011 Jan;96(1):F65-8. doi: 10.1136/adc.2010.186429.

  PMID: 21177753 BACKGROUND

• Janes M, Pinelli J, Landry S, Downey S, Paes B. Comparison of capillary blood sampling using an automated incision device with and without warming the heel. J Perinatol. 2002 Mar;22(2):154-8. doi: 10.1038/sj.jp.7210583.

  PMID: 11896522 BACKGROUND

• Aydin D, Inal S. Effects of breastfeeding and heel warming on pain levels during heel stick in neonates. Int J Nurs Pract. 2019 Jun;25(3):e12734. doi: 10.1111/ijn.12734. Epub 2019 Apr 17.

  PMID: 30993840 BACKGROUND

• WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138650/

  PMID: 23741774 BACKGROUND

• Hassan Z, Shah M. Scald injury from the Guthrie test: should the heel be warmed? Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F533-4. doi: 10.1136/adc.2005.072678.

  PMID: 16244215 BACKGROUND

• Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.

  PMID: 24476226 BACKGROUND

• Folk LA. Guide to capillary heelstick blood sampling in infants. Adv Neonatal Care. 2007 Aug;7(4):171-8. doi: 10.1097/01.ANC.0000286333.67928.04.

  PMID: 17700190 BACKGROUND

• Sorrentino G, Fumagalli M, Milani S, Cortinovis I, Zorz A, Cavallaro G, Mosca F, Plevani L. The impact of automatic devices for capillary blood collection on efficiency and pain response in newborns: A randomized controlled trial. Int J Nurs Stud. 2017 Jul;72:24-29. doi: 10.1016/j.ijnurstu.2017.04.001. Epub 2017 Apr 11.

  PMID: 28431226 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Heating

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Jonna Skov Madsen

  Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark

  STUDY DIRECTOR

• Patricia Diana Soerensen

  Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark

  STUDY CHAIR

• Ulla List Toennesen

  Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Also masked: Biomedical Laboratory Scientist
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: August 26, 2020
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)